Breaking: FDA Approves Moderna’s mRNA RSV Vaccine, mRESVIA

The FDA has approved mRESVIA (mRNA-1345) an mRNA respiratory syncytial virus (RSV) vaccine for adults aged 60 years and older to protect against lower respiratory tract disease caused by RSV infection.¹

The agency granted approval to mRESVIA under a breakthrough therapy designation.

Approval was based on positive data from the phase 3 ConquerRSV clinical trial (NCT05127434), a global study included approximately 37,000 adults from 22 countries aged 60 years and older. Study participants were randomly assigned 1:1 to receive either 1 dose of mRNA-1345 (50 µg) or placebo; primary efficacy endpoints included the prevention of RSV-associated lower respiratory tract disease with at least 2 signs or symptoms, and the prevention of RSV-associated lower respiratory tract disease with at least 3 signs or symptoms.

The initial results from this first phase of the study were published in the New England Journal of Medicine² in December 2023, with primary analyses conducted with approximately 3.7 months of median follow-up. Investigators found that vaccine efficacy was 83.7% (95.88% CI, 66-92.2) against RSV-associated lower respiratory tract disease with at least 2 signs or symptoms, and 82.4% (96.36% CI, 34-8-95.3) against RSV-associated lower respiratory tract disease with at least 3 signs or symptoms. Efficacy was 68.4% (95% CI, 50.9-79.7) against RSV-associated acute respiratory disease.

READ MORE: RSV Vaccine Coverage Similar to Flu Could Reduce Illness, Cost Burden

During the FDA review, a follow-up analysis of the primary endpoint, inclusive of cases that began before the primary analysis cut-off date, was conducted. These results were consistent with the primary analysis: vaccine efficacy was 78.7% (95% CI, 62.9%-87.8%), and an additional longer-term analysis demonstrated continued protection from the vaccine against RSV-associated lower-respiratory tract disease over an 8.6 month median follow-up period.

The most common adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia. No serious safety concerns were reported.

“The FDA approval of our second [RSV] product, mRESVIA, builds on the strength and versatility of our mRNA platform,” said Stéphane Bancel, Moderna CEO, in a news release. “mRESVIA proctects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of t administrative errors.”

“This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19,” Bancel added.

Each year, RSV is responsible for between 60,000 and 160,000 hospitalizations among older adults; between 6000 and 10,000 die each year due to RSV infection.

Moderna anticipates availability of mRESVIA for eligible adults by the start of the 2024/2025 respiratory virus season. Once available, mRESVIA will join 2 other RSV vaccines currently available: GSK’s Arexvy, currently approved for use in adults aged 60 years and older³ and Pfizer’s Abrysvo, approved for use in adults aged 60 years and older⁴ and in pregnant women between 32- and 36-weeks’ gestational age.⁵ Earlier this year, GSK was assigned a PDFUA date of June 7 for an expanded indication of Arexvy, to include adults aged 50 to 59 years who are at increased risk for RSV infection.⁶

READ MORE: Respiratory Resource Center

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References

1. Moderna receives US FDA approval for RSV vaccine mRESVIA. News release. Moderna. May 31, 2024. Accessed May 31, 2024. https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-U.S.-FDA-Approval-for-RSV-Vaccine-mRESVIAR/default.aspx

2. Wilson E, Goswami J, Baqui AH, for the ConquerRSV Study Group. Efficacy and safety of an mRNA-based RSV PreF vaccine in older adults. N Engl J Med. 2023;389;2233-2244. doi:10.1056/NEJMoa2307079

3. Biscaldi L. Breaking: FDA approves first-ever RSV vaccine. Drug Topics. May 3, 2023. Accessed May 31, 2024. https://www.drugtopics.com/view/breaking-fda-approves-first-ever-rsv-vaccine

4. Biscaldi L. FDA: Pfizer RSV vaccine approved for use in older adults. Drug Topics. June 1, 2023. Accessed May 31, 2024. https://www.drugtopics.com/view/fda-pfizer-rsv-vaccine-approved-for-use-in-older-adults

5. Meara K. FDA approves Pfizer RSV vaccine for use during pregnancy to protect infants. Drug Topics. August 22, 2023. Accessed May 31, 2024. https://www.drugtopics.com/view/fda-approves-pfizer-rsv-vaccine-for-use-during-pregnancy-to-prevent-rsv-in-infants

6. FDA: PDUFA date assigned for Arexvy as RSV prevention in age 50 to 59. Formulary Watch. February 8, 2024. Accessed May 31, 2024. https://www.drugtopics.com/view/fda-action-date-assigned-for-arexvy-as-rsv-prevention-in-age-50-to-59